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Engineered immune cells take on tough autoimmune diseases

NCT ID NCT07473154

Disease control Sponsor: Quell Therapeutics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-stage trial tests an experimental treatment called QEL-005 for people with two serious autoimmune conditions: diffuse cutaneous systemic sclerosis and difficult-to-treat rheumatoid arthritis. QEL-005 is made from a patient's own white blood cells, which are genetically modified in a lab to become special immune cells that target and calm overactive parts of the immune system. The study aims to check if the treatment is safe and tolerable, and to see if it can reduce disease activity. Participants will receive a single infusion of their modified cells and be followed for 15 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be at least 18 years of age at the time of signing the informed consent. * Up to date vaccination status and no planned vaccinations for post 3 months infusion * Adequate haematological, liver and renal function * Willing to undergo annual influenza vaccination * Willing to enter a 15-year follow-up * Eastern Cooperative Oncology Group (ECOG) performance status grade \< 3 * Able and willing to use a highly effective method of contraception * Stable dose of steroid prior to screening Specific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only: * Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria * Diagnosis of D2TRA per 2021 EULAR criteria * Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA * Evidence of inflammation in target joints used for the DAS28 CRP assessment Specific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only: * Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria * Serologically positive for antinuclear antibodies * Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). * Skin involvement with a total modified Rodnan Skin Score of at least 15 * Evidence of lung fibrosis based on imaging or pulmonary function testing * Evidence of active disease based on a validated SSc activity assessment Exclusion Criteria: * Presence of a significant medical condition(s), or clinically significant laboratory abnormality * History or concern of autoimmune diseases other than those under study * Active infection, or recurrent chronic infection requiring intervention * Immunodeficiency or receiving immunoglobulin replacement therapy * Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV * Clinically significant cardiac dysfunction or severe pulmonary impairment * Use of investigational agents within a pre-defined period prior to study screening * Received a previous cell therapy * Received certain B cell related experimental therapies in a clinical trial with the past year * Any solid organ, bone marrow or stem cell transplant * History of malignancy in the past 5 years * Receiving prohibited medication that cannot be stopped at screening

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Conditions

The condition(s) this trial relates to.

diffuse cutaneous systemic sclerosis diffuse scleroderma rheumatoid arthritis systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune rheumatologic disease Diffuse cutaneous systemic sclerosis Rheumatoid arthritis (RA Systemic sclerosis (SSC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Guy's & St Thomas NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • Hospital Universitario Fundacion Jimenez Diaz

    NOT_YET_RECRUITING

    Madrid, Spain

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, United Kingdom

  • Manchester University NHS Foundation Trust

    NOT_YET_RECRUITING

    Manchester, United Kingdom

  • Newcastle Upon Tyne NHS Foundation Trust

    RECRUITING

    Newcastle, United Kingdom

  • Royal Free London NHS Foundation Trust

    NOT_YET_RECRUITING

    London, United Kingdom

  • University Hospital Düsseldorf

    NOT_YET_RECRUITING

    Düsseldorf, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, United Kingdom

    Contact Email: •••••@•••••

  • University of Oxford - The Kennedy Institute

    RECRUITING

    Oxford, United Kingdom

  • Universitätsklinikum Erlangen

    NOT_YET_RECRUITING

    Erlangen, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.